#DBlogWeek ’13 – Day 2 – Petitioning the FDA
It’s Diabetes Blog Week again! For the next six days, I’ll be participating in the Fourth Annual Diabetes Blog Week (my second; you can find last year’s posts here). I’ll be taking cues from Karen and her assembled guest topic-suggesters Bitter-Sweet Diabetes.
Today’s Prompt: Recently various petitions have been circulating the Diabetes Online Community, so today let’s pretend to write our own. Tell us who you would write the petition to – a person, an organization, even an object (animate or inanimate) – get creative!! What are you trying to change and what have you experienced that makes you want this change?
NOTE: This is not a real petition. I suppose it could become one, but without credible citations and fact-checking, it is nothing more than my own airing of personal grievances.
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WHEREAS the manufacturers of most diabetes devices (including but not limited to insulin pumps, blood glucose meters, continuous glucose monitoring systems) are developed in the United States,
WHEREAS most diabetes devices debut in overseas markets prior to commercial introduction in the United States,
WHEREAS the regulatory process in the United States adds significant costs to diabetes device manufacturers and these costs are ultimately passed down to consumers,
WHEREAS minor enhancements of diabetes devices is discouraged in the United States, as the approval process is too overbearing for small improvements,
WHEREAS the continued use of obsolete device features and outdated user-interfaces are encouraged over newer, enhanced technology when evaluated on the basis of speed-to-market,
WHEREAS the financial burdens placed on diabetes devices and diabetes patients by the current regulatory environment is a detriment to healthcare costs and to the economy overall,
WHEREAS the withholding of the latest life-saving technology from diabetes patients is a detriment to the health and well-being of Americans,
WHEREAS the United States can only regain its status as the highest-ranked nation in terms of innovation and leadership if government regulations facilitate that end,
WHEREAS the corresponding regulatory bodies in other nations have permitted the use of more advanced, sophisticated diabetes devices than in the United States without significant adverse effects.
WHEREAS machines can not and should not be used to offset poor judgement of the people who use them, and
WHEREAS overly burdensome “safety” features often lead to circumvention of these features or procedures, rendering them useless,
THEREFORE, WE THE UNDERSIGNED petition the United States Food and Drug Administration to modify its operations to best serve the people, the businesses, and the economy of the United States.
WE ASK that all medical device submissions be evaluated in a reasonable and timely fashion,
WE ASK for transparency and periodic public updates on the review of submissions, including a progress-tracker, timeline, and any relevant findings,
WE ASK that the FDA act in the interests of national health and economic progress, while exercising a reasonable but not excessive degree of caution,
WE ASK that the safety of diabetes devices be evaluated on the reliability of the device to perform as intended, not on the ability of consumers to use the devices properly,
WE ASK, for diabetes devices that are not used for the administration of any drug or the dosing of any drug (i.e. continuous glucose monitoring systems), that a cursory review of the submission be sufficient to permit legal distribution of the device provided it is accompanied with a statement indicating that final FDA approval is still pending,
WE ASK that the FDA permit and encourage the development and publication of standard communications protocols, including both wired and wireless means, which will lead to interoperability of diabetes devices and third-party receivers developed by different manufacturers,
WE ASK that the Federal judicial system be empowered to subpoena the FDA for information relating to submissions currently or previously under review, to enforce timely reviews, and to rule on appeals.